Safety and efficacy of colistin versus meropenem in the empirical treatment of ventilator-associated pneumonia as part of a macro-project funded by the Seventh Framework Program of the European Commission studying off-patent antibiotics: study protocol for a randomized controlled trial

Table 2 Description of secondary variables

Definitions	Clinical efficacy	Microbiological efficacy	Timeframe
Cure	Complete resolution of all signs and symptoms of pneumonia.	Eradication of the bacterium causing ventilator-associated pneumonia during the treatment.	At 28 days of follow-up.
Failure	Persistence or progression of signs and symptoms.	Persistence of the bacterium causing ventilator-associated pneumonia during the treatment.	At 28 days of follow-up.
Relapse or recurrence	Recurrence of signs, symptoms and/or new radiographic evidence of pneumonia after final treatment.	Recurrence of signs, symptoms or new radiographic evidences of pneumonia present in the last evaluation and isolation of the initial pathogen.	At 28 days of follow-up.
			At any time after treatment finalization to end of follow-up.

ISSN: 1745-6215